Azithromycin
- Product NDC
- 80425-0219
- 11-digit product format
- 804250219
- Labeler code
- 80425
- Product ID
- 80425-0219_2a9aa22e-db40-217b-e063-6294a90a4c41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA065225
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 308460, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0219-1 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 3 |
| 80425-0219-1 | Azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0219 | AZITHROMYCIN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250102_f175496a-4ad3-ce0d-e053-2a95a90a6613.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0219-1 | 80425021901 | 1 BLISTER PACK in 1 CARTON (80425-0219-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-01-09 | 0000-00-00 | No | No | Current |